Suture loop for catheters

ABSTRACT

The present invention provides a device for securing a catheter or other tubing to a patient by means of suturing. The device comprises an adhesive backed strip having a first portion and a second portion defined by a fold line centered between the first and second portion along a transverse axis of the strip. Preferably, each portion has two holes formed therein with a channel provided between the holes along an axis parallel to the fold line. Thus, when the strip is folded along the fold line over a catheter or tubing, the channel of the first portion overlies the channel of the second portion forming a single channel within which the catheter or tubing is positioned, and the holes of the first portion overlie the holes of the second portion providing a hole on each side of the catheter or tubing to serve as a suture site.

FIELD OF INVENTION

The present invention relates to a suture loop which, if deemednecessary by the physician, can be used to secure a catheter or othertubing to a patient by means of suturing.

BACKGROUND OF THE INVENTION

In the medical field, it is often desirable to utilize a drug infusioncatheter to deliver several IV fluids to a patient at one time. Thefluids may include a parenteral fluid and one or more medications. Insuch a case, a drug infusion catheter with two or more delivery lumensmay be used. A typical drug infusion catheter is shown in FIG. 1.

When a drug infusion catheter is used, it is often left in the patient'svascular system for extended periods of time, sometimes as long as 48hours. In order to secure the catheter in place, the physician oftensutures the catheter to the patient at or near the insertion site. Thisprevents the catheter from pulling out or advancing further into thepatient's vascular system. This in turn prevents contamination of thepatient, which can occur if the catheter portion that has been outsidethe body and exposed to the environment slips into the patient's vessel.

In addition to drug infusion catheters, other types of catheters forother medical applications may also need to be sutured to the patient ator near the insertion site.

As shown in FIG. 1, suture loops are generally provided on the backform13 of a catheter, that is, the connector between the catheter 15 and theextension tubes 17 which communicate with the lumens in the catheter.Typically, the backform 13 is injection molded with a suture loop 11 oneither side as shown in FIG. 1. Thus, the suture loops 11 are integralwith the backform 13 of the drug infusion catheter 15.

The disadvantage of this type of suture loop is that if the catheter isnot inserted completely into the patient's vascular system, the sutureloops 11 may be positioned too distant from the insertion site toprovide proper catheter anchoring. Attempts to solve this problem haveresulted in a suture loop permanently positioned along the catheter tubeslightly distal of the backform as shown in FIG. 2.

The suture loop 19 is typically a separate injection-molded part formedof polyvinyl chloride that is adhesively-bonded directly to the catheter15 at the desired location during manufacture. This practice limits thesuture loop's utility to those cases where the catheter is inserted tosome predetermined depth. Unless the catheter is advanced to thepredetermined depth, the suture loop will not be positioned at thedesired location for properly anchoring the catheter. Adhesively-bondingthe suture loop to the catheter has the additional disadvantage ofcreating a stress-concentration and reducing the load-carryingcapability of the catheter body tubing. This type of suture loop alsohas an added cost of the labor involved in permanently attaching thesuture loop to the catheter during manufacture.

Attempts have been made to create a suture loop that can be positionedanywhere along the length of the catheter, such as the suture loop 21shown in FIG. 3. This type of suture loop is injection-molded withsuture loop holes 22 and a pre-formed slot 23 which permits the sutureloop to be slipped onto a catheter at any position along the length ofthe catheter tubing. The suture loop is typically formed of a pliableelastomeric material so that the slot can be opened to receive thecatheter but yet is resilient enough to partially close onto thecatheter.

Other suture loops have been provided similar to that shown in FIG. 3but without the pre-formed slot so that the suture loop is slid onto thecatheter over the catheter tip and slid to the desired location alongthe length of the catheter tubing prior to insertion of the catheterinto the patient. The disadvantage of these two suture loops is thatfluids from the patient's body, medical cleansing agents, medicationsand/or other liquids the patient might be treated with tend to wet thesurface of the catheter, causing fluid to enter the channel 25 formedwithin the suture loop. This can cause the suture loop to slip along thecatheter tubing resulting in unstable anchorage of the catheter.

OBJECTS AND SUMMARY OF THE INVENTION

It is therefore an object of the present invention to provide a sutureloop that can be placed anywhere along the length of the catheter tubingby the physician.

Another object of the present invention is to provide a suture loop thatwould minimize and would not be affected by accumulation of fluidswithin the channel surrounding the catheter tubing, thereby preventingthe problems associated with slippage of the suture loop.

The present invention in general provides a device for securing acatheter or other tubing to a patient by means of suturing. The devicecomprises an adhesive-backed strip with holes formed therein so thatwhen the strip is folded over the catheter or tubing with adhesive sidestogether, at least one hole is provided through which the catheter canbe sutured to the patient.

In one preferred embodiment, the adhesive-backed strip has a firstportion and a second portion separated by a fold line. The fold line ispreferably centered between the first and second portion along atransverse axis of the strip. Preferably, each portion has two holesformed therein with a channel provided between the holes along an axisparallel to the fold line. Thus, when the strip is folded along the foldline over a catheter or tubing, the channel of the first portionoverlies the channel of the second portion forming a single channelwithin which the catheter or tubing is positioned, and the holes of thefirst portion overlie the holes of the second portion providing a holeon each side of the catheter or tubing to serve as a suture site.

Preferably, the adhesive-backed strip is made of a polymeric material,such as a closed cell polyethylene foam, with adhesive coating on oneside and a pliant backing, preferably a plastic film adhesively attachedto the other side. The channels are then provided by forming a slit inthe polymeric material that does not penetrate the pliant backing. Theadhesive-backed strip could also be fabric or some other soft, pliablesubstance.

For shipping and handling, the suture loop is preferably applied to anoversized adhesive release liner so that the suture loop can easily begrasped and removed when needed. Preferably, the suture loop is mountedon the adhesive release liner in a T-formation wherein the inner ends ofthe first and second portions, which are adjacent to the fold line, arefolded with adhesive sides together, and the outer ends of each portionare applied to the adhesive release liner. The adhesively joined innerends provide a handle for the physician to grasp to quickly remove thesuture loop from the release liner and to manipulate the suture loop tothe desired position on the catheter or tubing prior to attaching it tothe catheter.

In the preferred embodiment, the channels provided in each portion ofthe adhesive-backed strip define the inner ends and the outer ends andfacilitate the manipulation of the adhesive strip into theT-configuration. When the inner ends are adhesively joined and the outerends are applied to the adhesive release liner, the channels form acrotch between the outer ends. The crotch serves as an indexing meansfor engagement with the catheter or tubing when the adhesive-backedstrip is removed from the release liner.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a drug-infusion catheter having suture loops integral with thebackform.

FIG. 2 is a drug-infusion catheter with a suture loop adhesively-bondedto the catheter tubing.

FIG. 3 is an injection-molded slip-on suture loop with a pre-formedslot.

FIG. 4 is a bottom view of a preferred embodiment of the suture loop ofthe present invention in its fully extended position.

FIG. 5 is a preferred embodiment of the suture loop of the presentinvention in a T-configuration mounted on an adhesive release liner.

FIG. 6 is a top view of the suture loop shown in FIG. 5.

FIG. 7 is a side view of the suture loop shown in FIG. 5.

FIG. 8 is a side view of the suture loop shown in FIG. 5 after it hasbeen removed from the release liner.

FIG. 9 is a top view of the suture loop of the present invention afterit has been attached to a catheter.

FIG. 10 is a cross-sectional view of the suture loop of the presentinvention taken along line 10--10 of FIG. 9.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIG. 4, a preferred embodiment of the suture loop of thepresent invention is shown in its fully-extended position. The sutureloop is an adhesive-backed strip with four holes 27 a, b, c and d formedtherein. A fold line 29 is provided in the center of the strip to assistin folding the strip over a catheter or other tubing. The holes 27a, b,c and are positioned along the adhesive strip on either side of the foldline 29 so that when the adhesive strip is folded onto itself, holes 27aand d correspond to each other and holes 27b and c correspond to eachother. The adhesive-backed strip is folded onto itself over a catheterso that the catheter is positioned between the pair of holes so formed.

In the preferred embodiment, four holes are provided in the strip sothat when the strip is folded over, one hole is provided on either sideof the catheter. However, in another embodiment two holes may beprovided in the strip so that when the strip is folded over thecatheter, only one hole is provided for suturing the catheter to thepatient. Alternatively, more than four holes could be provided so thatwhen the strip is folded over a catheter three, four or any number ofsuture holes are provided. The number of holes provided is not criticalto the invention, although two holes, one on either side of the catheteris preferred for stable anchoring.

Preferably, the adhesive strip shown in FIG. 4 has rounded outer edges31 and rounded inner edges 33 formed adjacent to the fold line 29. Therounded edges are a preferred choice, but outer edges 31 could besquared with no rounding of inner edges 33, thereby forming an elongatedrectangular strip which would function in the same way as the stripshown in FIG. 4.

Referring to FIG. 5, a preferred means of mounting the adhesive strip ofFIG. 4 on adhesive release paper for shipping and handling by thephysician is shown. Preferably, one-half of the adhesive strip is foldedonto itself and the other half provides outer ends which are splayedapart and mounted on adhesive-release liner 35. The suture loop mountedon the release liner in this way forms the general shape of a "T". TheT- configuration provides handle 37 which the physician can easily graspto remove the suture loop from the release liner 35 and which can beused to manipulate the suture loop to the desired position along thelength of the catheter tubing prior to joining the outer ends to eachother.

Although the T-configuration is the preferred configuration, the sutureloop could be provided on release liner in its fully extended positionas shown in FIG. 4 and simply peeled off by the physician prior tofolding it over a catheter.

Referring to FIG. 4, the T-configuration is more easily achieved byproviding channel 39a in the first portion 40a of the adhesive strip andchannel 39b in the second portion 40b of the adhesive strip. Channel 39ais positioned between holes 27a and 27b, parallel to fold line 29.Channel 39b is positioned between holes 27c and 27d, also parallel tofold line 29. Channels 39a and 39b overlie each other when the adhesivestrip is folded over the catheter tubing thereby creating a singlechannel through which the catheter tubing passes. The channel serves asa catheter indexing means for positioning and placement of the sutureloop around the catheter tubing. Channels 39a and 39b also facilitatebending the strip along lines 41a and 41b shown in FIG. 7 when inneredges 42a and b are folded together and outer edges 43a and b aresplayed apart to form the T- configuration.

A preferred material for the adhesive-backed strip is a laminate ofpolymeric foam tape coated on both sides with an agressive high shearadhesive system and a pliant backing applied to one side of the foamtape. The laminate construction is best shown in FIG. 7. The pliantbacking 36 is preferably a plastic film, such as a polyolefin, and thefoam tape is preferably a closed-cell polyethylene, both of which arecommercially available. A plastic film such as polyolefin is preferredbecause it is very strong and tear-resistant, yet pliable and soft tothe touch.

The foam tape is preferred because it has sufficient thickness andsoftness to grip the catheter without deforming the catheter but yet isresilient enough to provide a tight closure around the catheter whichtogether with the adhesive bonding to the catheter minimizesaccumulation of undesired fluids in the channel surrounding thecatheter. This in turn prevents slippage of the catheter once it hasbeen positioned by the physician at the desired location along thecatheter tubing. In the event there is some minimal fluid accumulation,the adhesive bonding also minimizes the slippage effect that fluidaccumulation would otherwise have.

The adhesive bonding to the catheter is facilitated by creating channels39a and 39b in the foam tape. As shown in FIG. 8, these channels arepreferably formed by slitting or cutting through the foam tape at 39aand 39b but not cutting through the pliant backing, thus when inneredges 42a and 42b are folded together, the outer edges 43a and 43b swingoutwardly to form a crotch 45.

The crotch allows for positive placement of the suture loop on thecatheter tubing by positioning the crotch over the tubing at the desiredlocation and then folding outer edges 43a and 43b together to seal thesuture loop around the catheter tubing. The preformed channels 39a and39b create a single channel when the suture loop is closed around thecatheter tubing and provide for a tighter fit around the catheter. Theair space in the channel around the catheter will be proportional to thebond strength of the adhesive on the strip. The channel may not benecessary if the adhesive on the strip is strong and will not separatedue to the resiliency of the catheter tube and if the strip material isof sufficient thickness and softness to conform around the cathetertubing.

In another preferred embodiment, adhesive coating on the foam tape isalso provided within the precut channels of the foam tape so that whencrotch 45 is positioned against the catheter tubing and outer edges 43aand 43b are folded together, all four edges of channels 39a and 39b gripthe catheter.

Referring to FIG. 6, there is shown a top plan view of theT-configuration. The rounded edges 33 on the preassembled adhesivelyjoined inner edges 42a and 42b are separated by fold line 29 which ispreferably a perforated line provided in pliant backing 36. Theperforation aids in folding the adhesive backed strip along fold line29. In addition, or in the alternative, a slit can be provided in thefoam tape or other material used for the strip at the fold line tofurther aid in folding the strip along the fold line. Like channels 39aand 39b the slit at the fold line would not be deep enough to penetratethe pliant backing.

Because of rounded edges 33, the length of fold line 29 is less than thelength of channels 39a and b. In another embodiment, rounded edges 33would not be provided and fold line 29 would be the same length asprecut channels 39a and 39b. The width of the adhesive strip would thusbe uniform along its length.

The flat pattern of the adhesive strip shown in FIG. 4 or in anotherembodiment, an elongated rectangular strip with squared edges, can beeasily mass produced by die cutting from a roll of the material used forthe adhesive backed strip. Accordingly, the suture loop of the presentinvention presents tremendous cost savings over prior art suture loopswhich are typically injection-molded plastic parts.

To use the suture loop of the present invention, the physician firstinserts the catheter into the patient to the proper depth, then graspsthe suture loop at its preassembled end (the adhesively joined innerends 42a and 42b), and pulls the suture loop off the release liner toexpose the adhesive. He then places the catheter in crotch 45 of thesuture loop, and with thumb and forefinger, brings the exposed adhesivetape around the catheter body and finally upon itself. He can then passsutures through the openings or holes in the suture loop to secure it tothe patient.

Referring to FIGS. 9 and 10, the suture loop of the present applicationis shown attached to a drug infusion catheter. FIG. 9 is a top view andFIG. 10 is a cross-sectional view taken along line 10--10 of FIG. 9.

When the suture loop is attached to the catheter, its total thickness ispreferably less than the minimum diameter of the catheter tubing. Thefoam tape is preferably 1/32 inch thick, the pliant backing ofpolyolefin is preferably 5 mil thick, and the acrylic coating ispreferably 1/2 mil thick. Any other dimensions are suitable for thesuture loop of the present invention.

The release liner paper is commercially available and is typicallysilicone treated paper. The release liner is preferably oversized sothat when the physician grasps the preassembled end, he can also grasp acorner of the liner and peel it off to expose the adhesive of the sutureloop. The oversizing of release liner 35 is

The foam tape with adhesive coating embodiment of the present inventionis advantageous because it firmly adheres to the catheter body anddistributes the restraining forces without creating any significantstress concentration effect. The conventional method of adhesive bondingof an injection molded suture loop to the catheter, as shown in FIG. 2,tends to create a stress concentration and reduces the load-carryingcapability of the catheter body tubing.

The adhesive-backed strip also provides the advantage of reducing thecost of labor involved in creating a separate molded part and adhesivelybonding it to the catheter during manufacture. The present inventionshifts the labor of locating the suture loop to the physician, thusproviding an immediate cost savings. The additional advantage of thesuture loop of the present invention is that by shifting the labor tothe physician, the suture loop can be placed precisely at the desiredlocation.

The invention described may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is therefore indicatedby the appended claim, rather than by the foregoing description. Allchanges which come within the meaning and range of the equivalency ofthe claims are to be embraced within their scope.

What is claimed is:
 1. A device for securing tubing to a patient bymeans of suturing, comprising:an elongated strip having two ends and twosides with adhesive applied to one side, said strip having a firstportion and a second portion, each portion having at least one holeformed therein and a channel formed on the adhesive side of the strip sothat when the adhesive side of the strip is folded over the tubing andthe ends are pressed together, the channels overlie each other forming asingle channel within the adhesively joined strip to secure the tubingin place, and the holes overlie each other to provide a suture site. 2.A device according to claim 1, wherein each portion has two holes formedtherein, one on each side of the channel, so that when the strip isfolded over the tubing, the holes in the first portion overlie the holesin the second portion providing a hole on each side of the tubing toserve as suture sites.
 3. A device according to claim 1 or 2, whereinthe adhesive side of the strip is applied to an adhesive release linerand removed from said liner when needed for suturing.
 4. A deviceaccording to claim 1 or 2, wherein the strip comprises foam tape withadhesive coating on one side and a pliant backing adhesively attached tothe other side.
 5. A device according to claim 1 or 2, wherein the stripcomprises foam tape with adhesive coating on one side and a pliantbacking adhesively attached to the other side and the channel providedin each portion of the adhesive strip is formed by a slit whichpenetrates the adhesive side of the foam tape but leaves the pliantbacking intact.
 6. A device according to claim 1 or 2, wherein the firstand second portions are separated by a fold line provided along atransverse axis of the strip and each portion has inner and outer endsdefined by the channel formed in each portion, the inner ends areadjacent the fold line, so that when the strip is folded along the foldline the inner ends of each portion can be adhesively joined and theouter ends of each portion can be applied to the adhesive release liner,the channels provided in each portion thereby forming a crotch betweenthe outer ends of each portion for engagement with the tubing when theouter ends are removed from the release liner.
 7. A device according toclaim 6, wherein the adhesively joined inner ends of each portionprovide means for grasping the strip for quick release from the releaseliner and for handling the strip and attaching it to the tubing.
 8. Adevice according to claim 1 or 2, wherein said channel in each portionof the strip is a slit formed in the adhesive side of each portion thatdoes not penetrate the strip completely.